SBIR-STTR Award

Radiation Sterilizable Small Size RFID Tags for Biomedical Samples
Award last edited on: 3/3/2021

Sponsored Program
SBIR
Awarding Agency
NIH : NIHOD
Total Award Amount
$3,686,486
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Hanan Davidowitz

Company Information

BioTillion LLC (AKA: Coldtrack LLC~Bio Tillion)

148 Tamarack Circle
Stillman, NJ 08558
   (609) 454-3523
   contact@biotillion.com
   www.biotillion.com
Location: Single
Congr. District: 07
County: Somerset

Phase I

Contract Number: 1R43OD020162-01
Start Date: 4/1/2015    Completed: 9/30/2015
Phase I year
2015
Phase I Amount
$231,757
The Specific Aim of this Phase I SBIR proposal is to test the feasibility of producing small, sterilizable RFI tags for use in ultra-low temperature storage samples vials. Many of millions of new biological samples are stored annually at research facilities, universities, hospitals, biobanks, pharmaceutical companies, etc. For the most part, tracking these samples is carried out manually or at best, using 1D or 2D bar codes. In many biobanks, regulations demand that all samples must be accounted for at all times and manual inventories are carried out on a regular basis. Performing these inventories by hand can cost a biobank thousands of person hours per year. In the case of samples in ultra-low temperature biobanks, manual searching for samples inevitably warms them and degrades them. Our company has addressed this problem for the ubiquitous 5.25" sample box. We have developed a unique RFID based method of tracking individual vials and boxes in the freezer of a biobank in real time. We are currently selling products and continue to develop that product line, but there are two significant barriers to more widespread use of RFID tags in the biomedical community. One is that current RFID tags cannot be sterilized in the same way as the vials they are meant to tag. The other is that the fastest growing market, SBS 96 formatted vials, is not addressed due to the small vial size. While many RFID tags can be sterilized using ethylene oxide or autoclaving, almost all vials are sterilized using either electron beam (e----beam) or gamma irradiation. Typical RFID tags are destroyed by both of these processes. In practice, this means that RFID tags and vials need to be attached after the sterilization process using sterile methods. This is not a practical solution because it adds additional handling and procedural steps and is prone to human error. We propose to develop an RFID tagged vial that will fit the SBS----96 formats and that can be sterilized using e beam or gamma irradiation. To achieve our Specific Aim, we will carry out the following tasks: Task #1: Develop a prototype RFID tag that will fit in an SBS----96 vial. Task #2: Make the RFID tag resistant to radiation sterilization. In Phase II, we will develop a commercial manufacturing method for producing encapsulated and sterilizable RFID tags as well as the supporting hardware and software for reading the tags. We expect to have a finished product at the end of Phase II.

Public Health Relevance Statement:


Public Health Relevance:
The number of archived biological samples is very large and ever growing. Maintaining large collections of these samples is fraught with difficulties arising from inadequate labeling technologies, the inability to automatically locate the samples and a lack of robust connection between the physical sample and archiving software. We propose to develop small, encapsulated, sterilizable RFID tags that can be built into modern sample vials and sterilized in situ. This will bring the advantages of RFID technology to the many forms of sterile plastic ware used in the biomedical community. This will reduce human errors, save cost, allow locating samples, and will minimize the need to handle frozen samples.

Project Terms:
Accounting; Address; Archives; Bar Codes; base; biobank; Biological; Boxing; Caliber; cold temperature; Communities; Computer software; cost; Devices; Electron Beam; Encapsulated; Engineering; Equipment and supply inventories; Ethylene Oxide; Failure (biologic function); Freezing; Funding; Goals; Hand; Hour; Human; In Situ; Individual; irradiation; Label; Legal patent; Letters; Manuals; Marketing; meetings; Methods; novel; Persons; Pharmacologic Substance; Phase; Plastics; Process; prototype; public health relevance; Radiation; Reading; Regulation; research facility; Risk; sample collection; Sampling; Small Business Innovation Research Grant; Solutions; Sterility; Sterilization; success; System; Technology; Testing; Time; University Hospitals; Vial device; Work

Phase II

Contract Number: 2R44OD020162-02
Start Date: 4/1/2015    Completed: 6/30/2018
Phase II year
2016
(last award dollars: 2020)
Phase II Amount
$3,454,729

The specific aim of this Phase II SBIR proposal is to develop a commercial method for manufacturing small sterilizable RFID tags for use in a bio-medical application; including ultra- low- temperature storage of samples vials. In our successful Phase I efforts, we showed feasibility of developing RFID tags that could withstand 25 kGy of e-beam irradiation, fit the bottom of an SBS-96 vial and function at -196o C. Hundreds of millions of new biological samples are stored annually. For the most part, tracking these samples is done manually. Tracking samples and performing required inventories using these manual methods leads to errors and is extremely time consuming. The lack of an automated tracking method has become an acknowledged problem in the field. Our company has addressed this problem for the ubiquitous 5.25” sample box. We have developed a unique RFID-based method of tracking individual vials and boxes in the freezer of a biobank in real time. Our success in developing a suitable RFID device was supported by a Phase I, Phase II, and IIb SBIR. We are currently selling products based on those findings and continue to develop that product line and will be beta testing an entire freezer/vial system at several sites in 2016, supported by the Phase IIb SBIR. There is currently a tremendous growth in the 96 vial SBS format. To use RFID based tags in this market the vials must withstand radiation sterilization because they are shipped preassembled in racks and ready for use. Currently available RFID tags are destroyed by irradiation. An additional challenge is making a small tag which that is tuned to the standard UHF RFID frequency range. In the Phase I we have shown that there is a clear path to creating an RFID tag that is sterilizable, has the appropriate tuning frequency, and is functional at temperatures down to -196 oC. We must now develop an affordable commercial method of manufacturing these tags. To this end, we will carry out the following tasks: 1) produce a sterilizable RFID chip, 2) use these chips to design a manufacturable RFID tag that fits the SBS-96 format vials and 3) port our manufacturing method to a commercial manufacturer.

Public Health Relevance Statement:
Project Narrative The number of archived biological samples is very large and ever growing. Maintaining large collections of these samples is fraught with difficulties arising from inadequate labeling technologies, the inability to automatically locate the samples and a lack of robust connection between the physical sample and archiving software. We propose to develop small, encapsulated, sterilizable RFID tags that can be built into modern sample vials and sterilized in situ. This will bring the advantages of RFID technology to the many forms of sterile plastic ware used in the biomedical community. This will reduce human errors, save cost, allow locating samples, and will minimize the need to handle frozen samples.

Project Terms:
abstracting; Accounting; Address; Affect; Archives; Automation; Bar Codes; base; biobank; Biological; Blood; Boxing; Caliber; cold temperature; Communities; Computer software; cost; design; Devices; Encapsulated; Equipment and supply inventories; Failure; Formalin; Freezing; Frequencies; Gamma Rays; Growth; Hand; Hour; Human; In Situ; Individual; irradiation; Label; Liquid substance; Logic; Manuals; Manufacturer Name; Marketing; Medical; meetings; Memory; Methods; Nitrogen; Paraffin Embedding; Persons; Pharmacologic Substance; Phase; prototype; Radiation; radioresistant; Regulation; Reporting; research facility; sample collection; Sampling; Shipping; Ships; Site; Small Business Innovation Research Grant; Sterility; Sterilization; success; System; Technology; Temperature; Testing; Time; Tissue Sample; University Hospitals; Vial device; Work